Improving Blood Pressure Control in End-Stage Renal Disease Through a Supportive-Educative Nursing Intervention

NCT01052220 | Completed DMC

• 3 other identifiers: 0904007039HIC# 2009-94020-2009
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

Brief Summary

The major purpose of this quantitative study is to determine if a 3 month supportive educative nursing intervention incorporating Blood Pressure (BP) education and BP, salt and fluid monitoring, in addition to goal setting and reinforcement will improve BP control in a chronic end-stage renal disease population.

Conditions

Hypertension; Hemodialysis

Keywords

Hypertension; Blood Pressure; End Stage Renal Disease; Hemodialysis; Interdialytic Weight Gain; Self-Regulation

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Average BPs were calculated from the hemodialysis flow sheets. Pre hemodialysis BPs were averaged to determine BP at baseline, 12 weeks and 16 weeks

  12 weeks and 16 weeks post intervention

Secondary Outcomes (1)

• Interdialytic Weight gain (IDWG) - Weight gain in kg between hemodialysis treatments

  12 weeks and 16 weeks post intervention

Study Arms (2)

BP Education and Self Regulation of BP

EXPERIMENTAL

The intervention will consist of 3 phases: 1) BP education sessions, 2) 12 week intervention and 3) 30 day post intervention follow-up period. The participants in the treatment group will received a BP educational session at baseline and were asked to monitor and record home BP daily, 24 hour fluid intake and complete a salt intake check-lists twice weekly for 12 weeks. The PI made weekly visits with the intervention participants in the HD unit to review BP and fluid logs and salt check lists with the participant to determine if predetermined goals for BP control were attained. When goals related to BP control are met, positive verbal reinforcement will be given to the participant. When goals related to BP control are not met, further exploration and problem solving will be done.

Behavioral: BP education and BP self-regulation; Behavioral: Supportive Educative Nursing Intervention

Usual Care

NO INTERVENTION

Participants in the usual care group did not receive the intervention but continued to receive their standard care in the hemodialysis unit which involved follow-up by the medical provider and BP medication adjustments as needed. .

Interventions

BP education and BP self-regulation BEHAVIORAL

The intervention will consist of 3 phases: 1) BP education sessions, 2) 12 week intervention and 3) 30 day post intervention follow-up period. The participants in the treatment group will be asked to monitor and record home BP daily, 24 hour fluid intake and complete a salt intake check-lists twice weekly for 12 weeks. The PI will visit weekly with the intervention participants in the HD unit. to review BP and fluid logs and salt check lists with the participant to determine if predetermined goals for BP control were attained. When goals related to BP control are met, positive verbal reinforcement will be given to the participant. When goals related to BP control are not met, further exploration and problem solving will be done.

Also known as: Home Blood Pressure Monitoring, Goal Setting, Reinforcement

BP Education and Self Regulation of BP

Supportive Educative Nursing Intervention BEHAVIORAL

BP Education, BP, salt and fluid monitoring, BP goal-setting, and reinforcement

Also known as: Self-regulation

BP Education and Self Regulation of BP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years
• average 4 week pre HD systolic BP \> 150 mmHg or diastolic BP \> 90 mmHg
• read and speak English.

You may not qualify if:

• on HD \< 6 months
• history of illicit drug use
• current major depression
• lack of orientation to person, time or place or score or \< 80 on the Modified Mini Mental Status Screen
• major health problems ie. terminal cancer or HIV
• missed \> 2 HD treatments over 4 weeks.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (2)

Davita Detroit Kresge Hemodialysis Unit

Detroit, Michigan, 48202, United States

Location

William Beaumont Hemodialysis Units

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Hypertension; Kidney Failure, Chronic; Self-Control

Interventions

Organizational Objectives; Reinforcement Machine Learning; Professional Autonomy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration; Machine Learning; Artificial Intelligence; Algorithms; Mathematical Concepts; Professional Practice

Study Officials

• Zorica Kauric-Klein, MSN

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomized to intervention group of standard care.

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 20, 2010
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (2)